CD19 CAR-T therapy! Gilead Yescarta's use of corticosteroids before infusion can reduce cytokine release syndrome and neurological events!

14, 2021 // -- Kite Pharma, a cell therapy company owned by Gilead, recently hosted the American Society for Transplantation and Cell Therapy (ASTCT) and the International Center for Blood and Bone Marrow Transplant research (CIBMTR) New results from the CD19 CAR-T cell therapy Yescarta (axicabtagene ciloleucel) trial for recurring or resusciable large B-cell lymphoma (LBLC) adult patients were presented at the Conference on Transplantation and Cell Therapy.
In the ZUMA-1 trial of a new safety management queue (queue 6), the primary purpose was to assess the effects of preventive use of corticosteroids and early use of corticosteroids and/or tocilizumab (toad monoantigen) therapy on the occurrence and severity of cytokine release syndrome (CRS) and neural events.
the queue, patients with relapsed or incurable LBCL were taken orally 10mg daily on the day of Yescarta infusion and for the next 2 days.
compared to ZUMA-1 critical queues (queues 1 and 2), queue 6 started using corticosteroids and toad monoantitors earlier, showing lower levels of CRS and neural events occurring.
40 patients who were in the queue 6 received at least one dose of corticosteroids.
in the preliminary analysis of queue 6, there were no level ≥3 CRS, ≥ level 3 neural events occurred in 13% of patients, and no level 5 neural events occurred in patients at the data cut-off time.
5 days for any level of CRS and 6 days for any level of neurological event.
68% of patients did not have CRS or neurological events within 72 hours of being injected with Yescarta.
95 percent of patients in the queue 6 showed therapeutic remission in Yescarta, 80 percent of whom achieved complete remission (CR), and 63 percent who still had remission at the data cut-off time (8.9 months in the study).
of the relief duration (DOR) has not yet been reached.
select closely matched subgroups from queue 6 and critical queues based on pre-specified LBCL patient prognostic factors for post-mortem bias scoring matching analysis.
the analysis compared the safety, effectiveness and pharmacodynamic/pharmacological characteristics of queue 6 with key queues.
in this subset of tendential scoring matches, the incidence of CRS at queue 6≥3 (0%) was lower than that of matching patients in the critical queue (13%), and the medium time delay for CRS incidence (5 days vs 2 days).
the severity and incidence of inter-queue neural events were similar when the tendency score was matched.
tendency score matching analysis shows that the mitigation rate of queue 6 is comparable to that of key queue.
car-T therapy is a live T-cell therapy product, unlike conventional small molecules or biological therapies.
Yescarta's principle is to genetically modify a patient's T-cells to express a chisellular antigen subject (CAR) designed to target antigen CD19, an antigen protein expressed on the surface of a variety of blood tumor cells, including B-cell lymphoma and leukemia cells.
Yescarta, approved by the FDA in October 2017, is the first CAR-T cell therapy to treat adult patients with relapsed or refractic large B-cell lymphoma (LBLC) with a specific adaptive disorder: for relapses or difficulty with 2 or more system therapies in the past Treatment in adult patients with therapeutic LBCL includes diffuse large B-cell lymphoma (DLBCL), primary vertical large B-cell lymphoma (PMBCL), high-level B-cell lymphoma (HGBL), and DLBCL (i.e., transformed FL, TFL) derived from fable lymphoma (FL).
yescarta is not suitable for the treatment of primary central nervous system lymphoma.
a black box warning about CRS and neurotoxicity risks in Yescarta's U.S. prescription information.
yescarta's approval was accompanied by a Risk Assessment and Mitigation Strategy (REMS).
, the preventive use of corticosteroids in conjunction with Yescarta treatment has not yet been approved by any regulatory authority.
the safety and effectiveness of this preventive adverse event management program require further clinical studies.
in China, Yescarta (Equilien seine injections, codenun FKC876) was developed by Fosun Kate Biotech Co., Ltd. (FOSUN Kite), a joint venture between Shanghai Fosun Pharmaceutical Group and Kate Pharmaceuticals.
In mid-March, Fosun Kate announced that the National Drug Administration(NMPA) Drug Review Center (CDE) had included a new drug listing application (NDA) for car-T cell therapy product Equililonsai Injection (NDA) as a priority review for treatment of second-line or above systems Adult patients with recurring or refractic large B-cell lymphoma after sexual therapy, including diffuse large B-cell lymphoma (DLBCL) non-special-fingered, primary vertical B-cell lymphoma (PMBCL), high-level B-cell lymphoma, and blistered lymphoma-transformed DLBCL.
Yikili Lunsai Injection (codenmost FKC876) is Fosun Kate's targeted CD19 in vitro CAR-T cell therapy product that introduced Yescarta (axicabtagene ciloleucel) technology from Kate Pharmaceuticals and is authorized to localize production in China.
the product is Fosun Kate's first CAR-T cell therapy product to be commercialized in China, and the first CAR-T cell therapy product officially accepted by the State Drug Administration (NMPA).
as a new cancer treatment, FKC876 can bring new hope and opportunity to patients with large B-cell lymphoma who have relapsed or are difficult to treat after receiving systemic treatment of second-line or above in China.
() Original source: Kite Announces New ZUMA-1 Cohort Analysis Evaluating Prophylactic Corticosteroid Use With Yescarta in Patients With With Relapsed or Refractory Large B-cell lymphoma